BioAgilytix, a  global bioanalytical Contract Research Organization (CRO), announces the expansion of its  Australian laboratories through the opening of a new purpose-designed facility for  360biolabs, a BioAgilytix company, in Sydney, Australia. 

Located within the Macquarie Park Innovation District, the new laboratory strengthens  360biolabs' established Australian bioanalytical footprint providing a permanent presence  in one of New South Wales' established science, health and technology precincts. The  location places 360biolabs close to clinical research sites, hospitals and research  institutions, supporting collaboration and timely processing of clinical trial samples. 

“Australia is a primary destination for early-phase clinical research, supported by a  streamlined regulatory pathway, rapid study start-up timelines, globally accepted data and  quality standards, and R&D tax incentives for eligible sponsors,” said Davide Molho, CEO of  BioAgilytix. “The new Sydney laboratory expands BioAgilytix’s Australian footprint through  360biolabs, alongside Melbourne and Brisbane, and strengthens our ability to support  sponsors as their programs advance across global regions.” 

Designed for time-sensitive clinical samples and complex early-phase studies, the BSL-2  facility supports PBMC isolation and flow cytometry. It also includes dedicated sample  reception and storage areas, ultra-low-temperature freezer capacity, vapour-phase nitrogen cryostorage and continuous temperature monitoring. 

The Sydney team brings assay development and validation expertise, supported by  360biolabs’ broader scientific network. Shared procedures, instrumentation and quality  systems support assay transfer and continuity from development through clinical sample  analysis and later-stage global programs. 

Through shared scientific leadership, procedures and quality systems, assays developed at  360biolabs can be transferred across BioAgilytix’s laboratories in Australia, Europe and the  United States. This supports continuity from first-in-human studies through later-stage  global programs, including integrated PK, immunogenicity and biomarker analysis.

“The Sydney laboratory marks the next stage of growth for 360biolabs in Australia,” said  Alistair Draffan, President of 360biolabs. “New South Wales has a strong and growing  clinical research sector, and establishing a permanent presence in Sydney allows us to  invest alongside that growth. It expands our ability to support clients locally, strengthens  our national business and creates a stronger foundation for continued growth in the region.” 

The Sydney facility has achieved accreditation from Australia’s National Association of  Testing Authorities (NATA) to ISO/IEC 17025. Across its Australian operations, 360biolabs  also holds NATA accreditation for Good Laboratory Practice (GLP) and Good Clinical  Laboratory Practice (GCLP). 

The Sydney expansion reinforces 360biolabs' commitment to supporting clinical research  in Australia while strengthening BioAgilytix's ability to provide coordinated bioanalytical  expertise across global drug development programs.